GenVec Inc has entered into a formal collaboration with the National Cancer Institute (NCI) by signing a Cooperative Research and Development Agreement (CRADA). Dr. Steven K. Libutti of the NCI Surgery Branch will conduct a Phase II clinical study to determine the activity of TNFerade, GenVec's lead oncology product candidate, in rectal cancer. TNFerade is currently being developed by GenVec and is in Phase II clinical trials for pancreatic and esophageal cancer.
Under the terms of this agreement, GenVec will provide the NCI with clinical supplies of its proprietary TNFerade product candidate for the study. Through the use of the NCI's imaging and proteomic capabilities, important information regarding TNFerade's mechanism of action and distribution is expected to be gained. In addition to this trial, the NCI will work with GenVec to test mutually agreed upon second-generation TNF (tumor necrosis factor) product candidates that target tumors when given systemically or regionally. These second-generation product candidates are based on GenVec's proprietary targeted gene delivery technology.
"This collaboration with the NCI broadens our TNFerade program," commented Dr. C. Richter King, GenVec's Vice President of Research. "The CRADA adds a highly experienced team of clinicians to the clinical testing of TNFerade. Using state-of-the-art methods employed by Dr. Libutti, we will further enhance our understanding of TNFerade's mechanism of action. Additionally, the CRADA supplements our development efforts with Fuso Pharmaceutical Industries, Ltd. of Japan. GenVec is now working with two great collaborators to explore TNF-based product candidates given locally, regionally, or systemically," Dr. King concluded.